Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease
Completed · Phase 4
Conditions studied: Sleep Disturbance, Fatigue, Inflammatory Bowel Disease
In brief
The purpose of this study is to determine if either a targeted type of talk therapy (Phase I) or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals with Inflammatory Bowel Disease (IBD).
Key facts
- Study ID
- NCT02162862
- Run by
- Eva Szigethy
- People needed
- 99
- Starts
- 2013-07-01
- Expected to finish
- 2016-06-30
- Last updated by the study team
- 2017-09-13
Who can join
Age: 15 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- IBD Group:
- Biopsy confirmed Crohn's Disease
- Qualifying scores on Multidimensional Fatigue Inventory and Pittsburgh Sleep Quality Index
- Healthy Volunteer Group:
- Does not meet any exclusion criteria
You may not qualify if…
- IBD Group:
- Meeting criteria for active alcohol or substance abuse or dependence
- Current ongoing treatment with Wellbutrin
- Females who are pregnant or plan to become pregnant within three months
- Sleep disorder such as apnea, restless leg syndrome or use of Continuous positive airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)
- Current IBD flare requiring hospitalization with intravenous steroid treatment
- Other acute medical conditions or a history of chronic inflammatory condition other than IBD
- Hemoglobin <10 with age and gender adjustments
- History of seizure disorder
- Acute infection within seven days
- Healthy Volunteer Group:
- History or current episode of psychiatric disorder by Diagnositic and Statistical Manual (DSM-IV)
- Current ongoing treatment with psychoactive medications
- Medications for sleep in previous two weeks
- Females who are pregnant or plan to become pregnant within three months
- History of IBD, epilepsy, rheumatoid arthritis, lupus
- Sleep disorder such as apnea, restless leg syndrome or use of Continuous positive airway pressure therapy (C-PAP)/Bilevel positive airway pressure (Bi-PAP)
Where it is running
- Presbyterian University Hospital of UPMC — Pittsburgh, Pennsylvania, United States
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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